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FDA 510(k)

MICROCOAGULATION PROTHROMBIN TIME TEST

K-Number: K940432 · 1994-05-18

ApplicantInternational Technidyne Corp.
Decision Date1994-05-18
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROCOAGULATION PROTHROMBIN TIME TEST is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K940432. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROCOAGULATION PROTHROMBIN TIME TEST?

MICROCOAGULATION PROTHROMBIN TIME TEST is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is International Technidyne Corp.. The 510(k) number is K940432.

When did MICROCOAGULATION PROTHROMBIN TIME TEST receive FDA 510(k) clearance?

MICROCOAGULATION PROTHROMBIN TIME TEST received FDA 510(k) clearance on 1994-05-18, under 510(k) number K940432.

Who is the listed applicant for MICROCOAGULATION PROTHROMBIN TIME TEST?

The FDA 510(k) record lists International Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROCOAGULATION PROTHROMBIN TIME TEST?

The FDA product code for MICROCOAGULATION PROTHROMBIN TIME TEST is GJS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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